International Registry to Assess Outcomes of Major Liver Resections Requiring Two Interventions Including the New Operation Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Morbidity and mortality (peripoerative)
研究概览
简要总结
Recently a new method of induce similar hypertrophy in the liver as is observed after hepatectomy has been described and was given the eponym "ALLPS". "ALPPS" stands for Associating Liver Partition with Portal Vein Ligation for Staged Hepatectomy (ALPPS).
Since the procedure is used worldwide this international registry was created to enable tracking of cases performed worldwide for safety and outcomes and innovations by the groups involved as well as allows a non-randomized comparison to the conventional methods of portal vein occlusion.
详细描述
The ALPPS registry is accessible online through the data portal www.allps.net. Registered members recieve access through a member ID and password. Data submission is supported by the SECUTRIAL software, supported by the Clinical Trials center of the University of Zurich.
All data submitted are anonymized before entry through the SECUTRIAL Software. Administration of the registry data is performed through the Department of Visceral and Transplantation Surgery in the University Hospital Zurich and the Clinical Trials Center of the University of Zurich, Switzerland, in collaboration with the Italian Hospital in Buenoas Aires, Argentina.
A Scientific Committee has been appointed to give approval for any data analysis. Any participating center may apply for data analysis.
Particiating International Centers have responsibility for the validity of the data submitted and the respective local institutional review procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Patients who undergo the new ALPPS procedure
- •Patients undergoing any other modification of ALPPS like portal vein embolization (PVE) or banding of the liver with portal vein ligation or embolisation or other liver resection in two stages resembling ALPPS_
- •Male and Female patients 18 years to no limit
- •Prior registering the data, patient was informed and did not object to the use of his/her anonymized medical data in this registry
排除标准
- •No exclusion criteria apply for a registry
结局指标
主要结局
Morbidity and mortality (peripoerative)
时间窗: 3 months
Primary outcome variablesis perioperative mortality and complications and survival status after 3 months. Data will be entered following the widely accepted Clavien-Dindo classification system .
次要结局
- Long term survival(5 years)
- Perioperative liver and renal function(5 days)
- Disease specific recurrence/failure to cure(5 years)
- Liver Growth as assessed by imaging-based volumetry(between stage 1 and stage 2 (1-12 weeks))